Manager Regulatory Compliance - Recalls

Medline Industries, Inc. in; Northfield Township (IL); On-site; USD 116,000 - 174,000; Full time

Benefits offered by this job

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP seeks a Manager Regulatory Compliance - Recalls (Education) to lead the recall team and ensure recalls and field actions comply with FDA regulations. The role involves planning, risk assessment, and cross-functional coordination with Quality, Regulatory, and Commercial teams.

The position requires 5+ years in medical device/pharma recalls, strong regulatory knowledge, and excellence in project management. Competitive benefits and salary are offered.

Qualifications

• 5+ years in the medical device or pharma industry, experience with product recalls, complaints, non-conformances, CAPAs, or similar activities involving field action, root cause analysis and problem solving.
• Experience with Microsoft Office Suite (Word, Excel, PowerPoint).
• Experience with SAP.
• At least 4 years of experience working with FDA/QSR/GMP/ISO requirements or other regulated industries.

Responsibilities

• Manage the recall team, providing coaching and development for team members.
• Support planning and execution of recalls, product corrections, and removals per FDA regulations.
• Contribute to recall decisions and strategy recommendations.
• Ensure timely submission of FDA Form 806 and related docs.
• Maintain compliance with 21 CFR Part 7 and 806.
• Support FDA communications and responses to recalls.

Skills

Recall management

FDA regulations

Project coordination

Communication

Microsoft Office

SAP

Team leadership

Regulatory submissions

Education

Bachelor's Degree in Engineering, Science, or related field

Associates Degree with 3+ years experience

Tools

Microsoft Office

SAP

Job description

Manager Regulatory Compliance - Recalls (Education)

Job Summary

Job Description

Major Responsibilities

• Manage the recall team, providing coaching and development for team members.
• Support the planning and execution of voluntary and mandatory recalls, product corrections, and removals in accordance with FDA regulations.
• Contribute to recall and field action decisions, including recall strategy recommendations.
• Ensure timely submission of FDA Form 806 and related documentation, including status reports and termination requests.
• Maintain compliance with 21 CFR Part 7 (Recall Policy) and 21 CFR Part 806 (Reports of Corrections and Removals).
• Support communications with FDA and assist in preparing responses related to recalls.
• Monitor regulatory changes related to field actions and adverse event requirements and escalates the impact to leadership.
• Track timelines and ensure deliverables are completed on schedule; provide updates to leadership on progress and risks.
• Facilitate and/or support cross-functional meetings to ensure alignment across stakeholders, including Quality, Regulatory, and Commercial teams.
• Manages a team of individual contributors and/or supervisors.
• Oversees day-to-day operations and execution of recall activities.
• Supports development and execution of projects and program deliverables.
• Implements and ensures adherence to established policies and procedures.
• Provides direction and guidance to team members on processes and expectations.
• Responsible for hiring input, performance management, and employee development.
• Assigns work, monitors progress, and ensures consistency in application of organizational policies.
• Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.

Education

• Bachelor's Degree in Engineering, Science, or related field or Associates Degree with 3+ years experience

Work Experience

• 5+ years of experience in the medical device or pharma industry, experience with product recalls, complaints, non-conformances, CAPAs, or similar activities involving field action, root cause analysis and problem solving.
• Experience with Microsoft Office Suite (Word, Excel, PowerPoint).
• Experience with SAP.
• At least 4 years of experience working with FDA/QSR/GMP/ISO requirements or other regulated industries.

Knowledge / Skills / Abilities

• At least 3 years of experience in recall management.
• Working knowledge of FDA regulations including 21 CFR Part 7, Part 806, Part 803, and ISO 13485.
• Experience supporting recall activities and regulatory submissions.
• Strong communication and project coordination skills.
• Experience supporting FDA audits or internal quality audits.

Preferred Job Requirements

Work Experience

• 5+ years of direct experience with recall management.
• Experience working in cross-functional regulatory or quality environments.

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:

$116,000.00 - $174,000.00 Annual

Manager Regulatory Compliance - Recalls (Education)

Job Summary

Job Description

Major Responsibilities

• Manage the recall team, providing coaching and development for team members.
• Support the planning and execution of voluntary and mandatory recalls, product corrections, and removals in accordance with FDA regulations.
• Contribute to recall and field action decisions, including recall strategy recommendations.
• Ensure timely submission of FDA Form 806 and related documentation, including status reports and termination requests.
• Maintain compliance with 21 CFR Part 7 (Recall Policy) and 21 CFR Part 806 (Reports of Corrections and Removals).
• Support communications with FDA and assist in preparing responses related to recalls.
• Monitor regulatory changes related to field actions and adverse event requirements and escalates the impact to leadership.
• Track timelines and ensure deliverables are completed on schedule; provide updates to leadership on progress and risks.
• Facilitate and/or support cross-functional meetings to ensure alignment across stakeholders, including Quality, Regulatory, and Commercial teams.

Management responsibilities include

• Manages a team of individual contributors and/or supervisors.
• Oversees day-to-day operations and execution of recall activities.
• Supports development and execution of projects and program deliverables.
• Implements and ensures adherence to established policies and procedures.
• Provides direction and guidance to team members on processes and expectations.
• Responsible for hiring input, performance management, and employee development.
• Assigns work, monitors progress, and ensures consistency in application of organizational policies.
• Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.

Minimum Job Requirements

Education

• Bachelor's Degree in Engineering, Science, or related field or Associates Degree with 3+ years experience

Work Experience

• 5+ years of experience in the medical device or pharma industry, experience with product recalls, complaints, non-conformances, CAPAs, or similar activities involving field action, root cause analysis and problem solving.
• Experience with Microsoft Office Suite (Word, Excel, PowerPoint).
• Experience with SAP.
• At least 4 years of experience working with FDA/QSR/GMP/ISO requirements or other regulated industries.

Knowledge / Skills / Abilities

• At least 3 years of experience in recall management.
• Working knowledge of FDA regulations including 21 CFR Part 7, Part 806, Part 803, and ISO 13485.
• Experience supporting recall activities and regulatory submissions.
• Strong communication and project coordination skills.
• Experience supporting FDA audits or internal quality audits.

Preferred Job Requirements

Work Experience

• 5+ years of direct experience with recall management.
• Experience working in cross-functional regulatory or quality environments.

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:

$116,000.00 - $174,000.00 Annual

The actual salary will vary based on applicant's location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here .

We're dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging pagehere .

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.